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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K182225
Device Name Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
Applicant
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Newark,  DE  19714
Applicant Contact Laura J. Duggan
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Newark,  DE  19714
Correspondent Contact Laura J. Duggan
Regulation Number862.1215
Classification Product Code
MMI  
Date Received08/16/2018
Decision Date 03/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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